Arterial or Venous ThrombosisNCT06650826
Study Regarding the Incidence of Anti-platelet Factor 4-antibodies in Patients Aged 18 to 60 Years With Spontaneous or Infection- or Vaccine-associated or Recurrent Venous and/or Arterial Thrombosis
An observational study of Arterial or Venous Thrombosis, run by Cardioangiologisches Centrum Bethanien at 2 sites in Germany.
Trial summary
Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arterial or Venous Thrombosis
- What is being tested?
- Determination of anti-platelet factor 4 antibodies in the blood
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2024to Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with venous and/or arterial thromboses that occur spontaneously, in association with infections or vaccinations or recurrently and are not associated with the presence of typical risk factors.
Who may be able to join
- Age between 18-60 years
- Written informed consent of the patient
- Spontaneous arterial and/or venous thrombosis
- infection-associated arterial and/or venous thrombosis within 30 days of infection
- Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
- Recurrent arterial or venous thrombosis despite anticoagulant therapy
Who cannot join
- Lack of consent of the patient
- Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
- Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
- Thromboses more than 120 days old at the time of blood sampling
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
Deutsches Herzzentrum der Charite (DHZC)
Berlin, 10117
Jana Last, MD, +4930450513142, jana_last@gmx.de
- Recruiting
Cardioangiologisches Zentrum Bethanien (CCB)
Frankfurt am Main, 60389
Edelgard Lindhoff-Last, Professor, +49-699450280, e.lindhoff-last@ccb.de
Edelgard Lindhoff-Last, Professor
About this study
Official title: The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis
Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis
Read the detailed description
Patients with venous and/or arterial thrombosis aged 18 to 60 years are included.Thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. In addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. The primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. For this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis.
As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.
- Conditions
- Arterial or Venous Thrombosis
- Being tested
- Determination of anti-platelet factor 4 antibodies in the blood
- Keywords
- Anti-PF4 antibodies, infections, vaccination
- Medical subject headings
- Venous Thrombosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of anti-platelet factor 4 antibodies in the bloodDiagnostic test
The anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up.
In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous arterial and/or venous thrombosis | Patients with spontaneous arterial and/or venous thrombosis Receives: Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood | |
| Infection-associated arterial and/or venous thrombosis | Patients with infection-associated arterial and/or venous thrombosis Receives: Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood | |
| Vaccine-associated arterial and/or venous thrombosis | Patients with vaccine-associated arterial and/or venous thrombosis Receives: Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood | |
| Recurrent arterial and/or venous thrombosis despite anticoagulant therapy | Patients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy Receives: Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial or Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
- Investigators
- Edelgard Lindhoff-Last, Professor, Principal investigator, Cardioangiologisches Zentrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650826
- Sponsor's protocol ID
- APIT
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APIT Study: Prospective Observational Study of the Incidence of Anti-platelet Factor 4 Antibodies in Suspected Immune-associated Arterial and/or Venous Thrombosis
- ClinicalTrials.gov ID
- NCT06650826
- Acronym / sponsor ID
- APIT
- Conditions
- Arterial or Venous Thrombosis
- Keywords
- Anti-PF4 antibodies, infections, vaccination
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis
Detailed description
Patients with venous and/or arterial thrombosis aged 18 to 60 years are included.Thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. In addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. The primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. For this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis.
As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spontaneous arterial and/or venous thrombosis | – | Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the bloodPatients with spontaneous arterial and/or venous thrombosis |
| Infection-associated arterial and/or venous thrombosis | – | Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the bloodPatients with infection-associated arterial and/or venous thrombosis |
| Vaccine-associated arterial and/or venous thrombosis | – | Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the bloodPatients with vaccine-associated arterial and/or venous thrombosis |
| Recurrent arterial and/or venous thrombosis despite anticoagulant therapy | – | Diagnostic Test: Determination of anti-platelet factor 4 antibodies in the bloodPatients with recurrent arterial and/or venous thrombosis despite anticoagulant therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with venous and/or arterial thromboses that occur spontaneously, in association with infections or vaccinations or recurrently and are not associated with the presence of typical risk factors.
Key inclusion criteria (6 listed)
- Age between 18-60 years
- Written informed consent of the patient
- Spontaneous arterial and/or venous thrombosis
- infection-associated arterial and/or venous thrombosis within 30 days of infection
- Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
Key exclusion criteria (4 listed)
- Lack of consent of the patient
- Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
- Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
- Thromboses more than 120 days old at the time of blood sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of anti-platelet factor 4 antibodies in the bloodThe anti-platelet factor 4 antibodies in the blood are determined using latex agglutination and the chemiluminescence method in the coagulation laboratory of the CCB MVZ laboratory. In addition, the platelet factor 4-induced platelet activation test (PIPA test) and the heparin-induced platelet activation test (HIPA test) as well as an ELISA-based platelet factor 4 IgG antibody test (Prof. Greinacher, Greifswald University Hospital) will be performed as part of the routine work up. In addition a new assay for heparin-independent anti-PF4 antibody detection provided by the company Werfen using chemiluminescence will be performed. | Diagnostic test | Infection-associated arterial and/or venous thrombosis, Recurrent arterial and/or venous thrombosis despite anticoagulant therapy, Spontaneous arterial and/or venous thrombosis, Vaccine-associated arterial and/or venous thrombosis |
Primary outcome
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
Time frame: Day 1
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edelgard Lindhoff-Last, Professor principal investigator
Cardioangiologisches Zentrum Bethanien
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial or Venous Thrombosis, run by Cardioangiologisches Centrum Bethanien at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edelgard Lindhoff-Last, Professor (+49-699450280, e.lindhoff-last@ccb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of anti-platelet factor 4 antibodies in temporal connection with the occurrence of arterial and/or venous thrombosis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.